Judge rules on gastroparesis evidence in GLP-1 lawsuits against Novo Nordisk and Eli Lilly
A federal judge's August 2025 ruling set what stomach-emptying evidence a gastroparesis claim needs, shaping which GLP-1 lawsuits can move forward.
A federal judge has ruled on what medical evidence is needed to support a gastroparesis claim in the consolidated federal lawsuits over GLP-1 medications, a decision that shapes which cases can proceed in the litigation known as MDL 3094 [1][2].
Judge Karen S. Marston of the Eastern District of Pennsylvania issued the ruling in August 2025 [1][2]. It runs 78 pages and followed more than 3,700 pages of briefing and evidentiary hearings [1]. The decision addressed one of three questions the judge asked the parties to resolve before any test trials: whether plaintiffs must present specific diagnostic testing evidence [2]. The other two — whether federal law preempts the claims, and whether there is enough general causation evidence linking the drugs to gastrointestinal injuries — were left unaddressed in the August ruling [2].
The court requires objective diagnostic testing for gastroparesis claims [1]. A gastric emptying study, also called scintigraphy, involves eating a meal containing a small amount of radioactive material while imaging tracks how quickly food leaves the stomach. The National Institute of Diabetes and Digestive and Kidney Diseases describes diagnosis as requiring more than 10% retention at four hours [1]. Gastroparesis, sometimes called stomach paralysis, is a disorder that slows or stops food moving from the stomach to the small intestine, with symptoms that can include severe nausea, vomiting, bloating and malnutrition [1]. How the ruling treats claims that lack a gastric emptying study has not been reported.
MDL 3094 was created in February 2024 and is before Judge Marston [1]. Defendants include Novo Nordisk, which makes Ozempic, Wegovy and Rybelsus (all semaglutide), and Eli Lilly, which makes Mounjaro and Zepbound (tirzepatide) and Trulicity (dulaglutide) [1][2]. As of September 2026, 4,022 cases were pending out of 4,056 filed, up 202% since January 2025 [1]. About 75% of complaints allege gastroparesis or stomach paralysis, 18% allege ileus and 8% allege gallbladder injuries [1]. In December 2025, the case count was described as nearly 3,000 [2]; monthly figures show 2,947 that month [1].
The ruling came against a backdrop of research and label changes. An October 2023 study by Sodhi and colleagues in JAMA found that patients using GLP-1 drugs for weight loss had higher risks of several gastrointestinal events: 3.67 times the risk of gastroparesis, 4.22 times the risk of bowel obstruction and 9.09 times the risk of pancreatitis [1]. Delayed gastric emptying is a known mechanism of these drugs; plaintiffs argue the labels did not adequately warn that the effect could persist after stopping treatment or progress to severe gastroparesis [1]. In October 2025, the FDA added language to the Ozempic label stating the drug "is not recommended in patients with severe gastroparesis" [1].
Why it matters for patients
Patients who believe a GLP-1 medication caused stomach problems face a documentation question that now carries legal weight. A gastric emptying study showing delayed emptying is described as the strongest support for a gastroparesis claim [1]. Many people who take these drugs never have that test, and how the court handles those cases has not been reported.
The ruling governs lawsuits, not medical care. The Ozempic label states the drug is not recommended for patients with severe gastroparesis [1]; that is a separate matter from what evidence a court will accept.
The decision is also not a finding on whether the drugs caused the injuries. The general causation question — whether there is enough scientific evidence linking the medications to gastrointestinal injuries — remains pending [2]. No settlements have been announced [1][2].
What happens next
The court set deadlines for the remaining issues in a December 16, 2025 case management order [2]:
- Plaintiffs' expert reports: January 2, 2026
- Defendants' expert reports: February 12, 2026
- Plaintiffs' rebuttal reports: February 23, 2026
- Expert depositions completed: April 10, 2026
- Motions to exclude expert opinions (Daubert motions): April 28, 2026
- Summary judgment motions: April 30, 2026
- Briefing continues through July 24, 2026
Bellwether trial selection is expected around mid-2026, with first trials possible in late 2026, and settlements considered unlikely before late 2027 [1]. A separate MDL, 3163, handles vision-loss claims involving NAION; it was created in December 2025, has about 200 cases and is also before Judge Marston [1][2].
Sources
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